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pci biotech holding asa (PCIB) Details

PCI Biotech Holding ASA, a cancer focused biopharmaceutical company, develops therapeutic products based on its proprietary photochemical internalisation (PCI) technology. The PCI technology induces triggered endosomal release and may be used to unlock the true therapeutic potential of various modalities, such as small molecules, ADCs, and siRNA. The company’s programs in clinical development include the photosensitizer Amphinex, which is in Phase II clinical trials for the treatment of head and neck cancer, as well as in Phase I/II clinical trials for the treatment of bile duct cancer. It is also developing PCI as a CTL induction technology for therapeutic and prophylactic vaccination. PCI Biotech Holding ASA was founded in 2000 and is headquartered in Lysaker, Norway.

pci biotech holding asa (PCIB) Key Developments

PCI Biotech Holding ASA Reports Consolidated Earnings Results for the Fourth Quarter and Full Year December 31, 2014

Feb 24 15

PCI Biotech Holding ASA reported consolidated earnings results for the fourth quarter and full year December 31, 2014. For the quarter, the company reported other income of NOK 1.54 million compared to NOK 1.98 million a year ago. Operating loss was NOK 10.27 million compared to NOK 9.32 million a year ago. Ordinary loss before taxes was NOK 10.21 million compared to NOK 8.85 million a year ago. Net loss was NOK 10.21 million compared to NOK 8.85 million a year ago. Net cash flow used in operations was NOK 3.89 million compared to NOK 5.93 million a year ago.
For the year, the company reported turnover of NOK 7.30 million compared to NOK 6.68 million a year ago. Operating loss was NOK 36.47 million compared to NOK 29.33 million a year ago. Ordinary loss before taxes was NOK 35.84 million compared to NOK 27.61 million a year ago. Net loss was NOK 35.84 million compared to NOK 27.61 million a year ago. Net cash flow used in operations was NOK 30.84 million compared to NOK 26.88 million a year ago.

PCI Biotech Holding ASA Announces Completion of the Third Group in the Intra-Tumour Light Dose Escalation Part of the Enhance Study

Feb 20 15

PCI Biotech Holding ASA reported that the treatment evaluation of the third group in the intra-tumour light dose escalation part of the ENHANCE study has been completed.- ENHANCE is a phase II study of Amphinex- in combination with the cytotoxic agent bleomycin in recurrent head and neck cancer patients. No safety concerns were raised and clear tumour responses with clinical benefits were seen at this light dose level. However, re-growth of tumour in the rim of the treatment area in some patients suggests a need to increase the treatment margins to achieve a durable disease response. A Dose Review Committee (DRC) of clinical experts and company representatives has been established to evaluate the results and provide recommendation for the continuation of the study. The DRC has recommended that an additional cohort of three patients is treated at the same light dose level, but with a modified treatment strategy extending the treatment margins. Patients for the next group are currently being screened and will be treated with Amphinex- as soon as possible.

PCI Biotech Receives Clearance by the United States Food and Drug Administration to Include Patients in the USA in Its Phase II Clinical Programme for Amphinex

Jan 20 15

PCI Biotech announced that it has received clearance by the United States Food and Drug Administration (FDA) to include patients in the USA in its phase II clinical programme for Amphinex. Amphinex is in development as a new local treatment for recurrent head and neck cancer and the phase II program has already been initiated in Europe.

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